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Completed

NCT Number: NCT06826742

Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.

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Key information

Conditions

Cesarean Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking
  • Age over 18 years old
  • Scheduled cesarean delivery

Exclusion criteria

  • Any contraindication to the administration of a spinal technique for anesthesia
  • History of intolerance or adverse reaction to opioid medications
  • History of chronic pain, opioid use >30 OME/day, or substance use disorder
  • History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 <92% on room air, or has a pre-existing oxygen requirement)
  • History of liver or kidney failure
  • Diagnosis of pre-eclampsia with current pregnancy
  • Depression requiring more than one medication
  • Planned use of CSE technique
  • BMI >50.0 kg/m2
  • ASA status IV, V
  • No prior history of an ECG demonstrating QTc > 440ms
  • Surgical complication requiring conversion to general anesthesia

Treatment and study plan

Intravenous line (IV) Methadone

Drug

Subjects will receive standardized spinal anesthesia without intrathecal morphine (intrathecal 1.6-2 mL 0.75% bupivacaine + dextrose, 15 mcg fentanyl) and intravenous methadone (0.2mg/kg total body weight up to max dose of 20 mg, with saline added to make total volume 2 mL)

The Intravenous line (IV) methadone will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.

Intrathecal morphine

Drug

Subjects will receive standardized spinal anesthesia with intrathecal morphine 150 micrograms and no methadone (2cc dose of IV normal saline)

The Intravenous line (IV) saline will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.

Primary outcomes

  1. Total opioid consumption

    Time frame: 24 hours post-delivery, 48 hours post-delivery

    Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.

Secondary outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool

    Time frame: 24 hours, 48 hours, 7 days

    The Obstetric Quality of Recovery-10 (ObsQoR-10), is a patient-reported 10-item questionnaire used to assess quality of recovery following spinal administration of pain medication. Patients rate each recovery item on a scale of 0 to 10, with 0 = worst possible recovery and 10 = best possible recovery. Total score ranges from 0-100 with higher scores indicating a better recovery after childbirth.

  2. Numeric Rating Scale (NRS) pain score at rest

    Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days

    A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced at rest and is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".

  3. Numeric Rating Scale (NRS) for movement-evoked pain

    Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days

    A Numeric Rating Scale (NRS) score for movement-evoked pain is a patient-reported item regarding the level of pain experienced with provoking maneuvers such as cough, inspiration/expiration, sitting up, knee flexion, hip flexion, rolling over in bed, and walking. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".

  4. Numeric Rating Scale (NRS) for pain in previous 24 hours

    Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days

    A Numeric Rating Scale (NRS) score for highest level of pain is a patient-reported item regarding the level of pain experienced in the last 24 hours. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".

  5. Pruritus

    Time frame: 12 hours, 24 hours, 36 hours, 48 hours

    The severity of pruritus post spinal administration will be patient-reported on a 4-point Likert scale where 0 = none and 3 = severe.

  6. Richmond Agitation Sedation Scale (RASS)

    Time frame: 12 hours, 24 hours, 36 hours, 48 hours

    The Richmond Agitation Sedation Scale (RASS) will be used to assess the level of alertness and agitated behavior in patients. The patient's level of consciousness and sedation are rated by care provider, ranging from a combative state (+4) to an unarousable state (-5), with a "calm and alert" score at 0.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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